A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

Phase 3

Recruiting

• Conditions: Melanoma
• Interventions: Drug: ABP 206; Drug: Nivolumab

• Registration Number: NCT06054555
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

Detailed Description

Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab).

All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment.

The total duration of study participation for each subject will be approximately 26 months.

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-26
• Study Start: 2023-11-02
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-18
• Primary Completion: 2027-01-25
• Study Completion: 2027-01-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

• At least 18 years of age.
• Histologically confirmed unresectable or metastatic melanoma.
• Subject has no prior systemic treatment for advanced disease.
• Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
• Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Key

Exclusion Criteria

• Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.
• Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.
• Subject has active central nervous system (CNS) metastases not previously treated.
• Ocular melanoma.
• Subject has active or known immune-mediated disorders.
• Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.
• Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product.

Other protocol-defined inclusion/exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABP 206	ABP 206	Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
Nivolumab	Nivolumab	Subjects will receive Dose A of Nivolumab via IV infusion.

Primary Outcome Measures

Name	Time	Method
Objective response by Week 49	Week 49
Objective response at Week 17	Week 17
Progression-free survival (PFS)	From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
Overall survival (OS)	From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Duration of response (DOR)	From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)

Secondary Outcome Measures

Name	Time	Method
Number of subjects with treatment-emergent adverse events of interest	Week 1 until Week 105
Number of subjects with anti-drug antibodies	Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105
Serum concentrations of ABP 206 and nivolumab (Ctrough)	Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105
Number of subjects with treatment-emergent adverse events	Week 1 until Week 105
Number of subjects with treatment-emergent serious adverse events	Week 1 until Week 105

Trial Locations

Locations (182)

Cancer and Blood Specialty clinic; 🇺🇸 Long Beach, California, United States

Fort Wayne Medical Oncology and Hematology - Office of Clinical Research; 🇺🇸 Fort Wayne, Indiana, United States

Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion; 🇺🇸 Baton Rouge, Louisiana, United States

University of Maryland Medical Center-Greenebaum Cancer Ctr; 🇺🇸 Baltimore, Maryland, United States

Oncology Hematology Associates; 🇺🇸 Springfield, Missouri, United States

Hematology-Oncology Associates-CNY; 🇺🇸 East Syracuse, New York, United States

Fundación CENIT; 🇦🇷 Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina

Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology; 🇦🇷 Mar del Plata, Río Negro, Argentina

Clínica Viedma; 🇦🇷 Viedma, Río Negro, Argentina

Instituto de Oncologia de Rosario; 🇦🇷 Rosario, Santa Fe, Argentina

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